510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032078Substantially Equivalent

Mitek Micro Quickanchor

Mitek Worldwide, Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032078 is the FDA 510(k) clearance record for MITEK MICRO QUICKANCHOR, a class II device, cleared for Mitek Worldwide on under FDA product code NOV (Anchor, Suture, Bone Fixation, Metallic). FDA's definition for product code NOV reads: "This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim". FDA records list 10 510(k) clearances for Mitek Worldwide, from to . As of , FDA records show no recalls naming K032078.

Clearance record

Decision date
Received
(49 days to decision)
Product code
NOV Anchor, Suture, Bone Fixation, Metallic
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Mitek Worldwide A Johnson & Johnson Company, Norwood MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOV

Trailing 12 months

FDA records hold no clearances under product code NOV in the trailing twelve months.

FDA records show no clearances under product code NOV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260